BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 14342521 · Received May 9, 2022

    Report

    Report Number
    3012236936-2022-01221
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 21, 2022
    Report Date
    August 23, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739543
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TELEPHONE NUMBER: (B)(6). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS OBSERVED THAT SECTION "G2" SHOULD HAVE INCLUDED "COMPANY REPRESENTATIVE" WHICH INADVERTENTLY WAS NOT SELECTED IN THE INITIAL MDR REPORT, AND IT WAS ALSO NOTED THAT THE SECTION "G4" OF THE INITIAL MDR REPORT WAS INADVERTENTLY POPULATED WITH THE PMA# P980040 WHICH IS INCORRECT. THE "G4" FIELD SHOULD HAVE BEEN KEPT EMPTY AND THE JUSTIFICATION FOR THAT SHOULD HAVE BEEN CAPTURED TO THE SECTION "H10" OF THE INITIAL MDR REPORT. THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION G2 REPORT SOURCE ADDED: COMPANY REPRESENTATIVE SECTION G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS EYHANCE OPTIBLUE SIMPLICITY, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY TECNIS EYHANCE IOL MODEL DIB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: RETURNED TO MANUFACTURER: YES SECTION D9: DATE RETURNED TO MANUFACTURER: MAY 17, 2022 SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: THE COMPLAINT HANDPIECE WAS RECEIVED INSIDE OF THE ORIGINAL FOLDING CARTON. GAUZE WAS RECEIVED IN A BAG. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE GAUZE RECEIVED DID NOT HOLD THE ALLEGED RED FIBER DESCRIBED IN THE COMPLAINT. THE HANDPIECE WAS INSPECTED AS WELL. THE HANDPIECE WAS DISASSEMBLED AND EACH COMPONENT WAS INSPECTED, NO RED FIBER COULD BE FOUND INSIDE OF OUR OUTSIDE OF THE HANDPIECE AND NO FURTHER ISSUES COULD BE IDENTIFIED WITH THE HANDPIECE. THE CUSTOMER PROVIDED PHOTOS WERE EVALUATED AND THE ALLEGED "FIBER" CAN BE OBSERVED, HOWEVER THE ROOT CAUSE CANNOT BE CONFIRMED FROM A PHOTO ASSESSMENT. THE COMPLAINT ISSUE WAS NOT CONFIRMED. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHEN AN INTRAOCULAR LENS (IOL) WAS BEING INSERTED INTO THE PATIENT'S OPERATIVE EYE, A RED FILAMENT CAME OUT WITH THE LENS. ACCOUNT INDICATED THAT THE FOREIGN MATERIAL WAS REMOVED AND THE IOL REMAINS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065113 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739543

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown